In a Double-Blind RCT for evaluation of Pentoxyphilin effect on Diabetic foot ulcer, 22 patients with foot ulcers (grade 1 & 2 Wagner classification) were enrolled into two groups. Intervention group received Pentoxyphilin 400 mg/day and control group received placebo. Patients were followed for 3 months and compared in terms of rate of healing, side effects and need to debridment or amputation. Patients were excluded from the study if amputation or debridment needed. Patients were also identical in terms of blood sugar and nutritional state (HbA1C one unit upper than upper limit, Alb more than 3.5). Patients who had peripheral vascular disease, history of consumption of drugs that may influence wound healing or coagulation system, contraindications for Pentoxyphilin (Ischemic heart diseases, Retinal hemorrhage, and Cerebral hemorrhage) were excluded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138708041399N1
Registration date:2009-04-28, 1388/02/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-04-28, 1388/02/08
Registrant information
Name
Setareh Soltany
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1446 3401
Email address
soltany@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2005-07-21, 1384/04/30
Expected recruitment end date
2006-07-21, 1385/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Pentoxyphilin in treatment of diabetic foot ulcers
Public title
Evaluation of the effect of Pentoxyphilin in treatment of diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Presence of NIDDM (Non insulin dependent diabetes mellitus), presence of foot ulcer, HbA1C one unit more than normal range. Exclusion Criteria: Serum Alb<3.5 mg/dL, presence of peripheral vascular disease, non-palpable Dorsalis pedis & Tibialis posterior pulses, consumption of Glucocorticoids and Warfarin, contraindication for Pentoxyphilin.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan university of medical sciences
Street address
Basij blvd., Semnan
City
Semnan
Postal code
Approval date
2005-05-30, 1384/03/09
Ethics committee reference number
182
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E11.5
ICD-10 code description
Non-insulin-dependent diabetes mellitus With peripheral circulatory complications
Primary outcomes
1
Description
Healing of diabetic foot ulcer
Timepoint
Baseline, every one month for 3 months
Method of measurement
Decrease of the wound size relative to original size: length in Linear wounds (mm), surface in planar wounds (mm^2), volume in 3 dimensional wounds (mm^3)
Secondary outcomes
1
Description
Drug adverse effects
Timepoint
3 months
Method of measurement
Clinical manifestations of Dizziness or Retinal hemorrhage
2
Description
Need to debridement
Timepoint
3 Months
Method of measurement
proportion of patients who need debridment
3
Description
Need to amputation
Timepoint
3 months
Method of measurement
proportion of patients who need amputation
Intervention groups
1
Description
Pentoxyphiline (Oral capsule, 400 mg, BID for 3 months)
Category
Treatment - Drugs
2
Description
Flour filled capsules as placebo(Oral capsule like Penthoxyphilin, BID for 3 months)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital of Semnan
Full name of responsible person
Street address
City
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan university of medical science
Full name of responsible person
Dr Raheb Ghorbany
Street address
Iran, Semnan, Basij boulvard, Central setad of University
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Setareh Soltany
Position
Assistant professor of surgery, General surgeon
Other areas of specialty/work
Street address
Iran, Semnan, Amiralmomenin Hospital
City
Semnan
Postal code
Phone
+98 23 1446 3401
Fax
Email
soltany@sem-ums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Setareh Soltany
Position
Assistant professor of surgery, General surgeon
Other areas of specialty/work
Street address
Iran, Semnan, Amiralmomenin Hospital
City
Semnan
Postal code
Phone
+98 23 1446 3401
Fax
Email
soltany@sem-ums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Jafar Alavy Toussy
Position
Pathologist
Other areas of specialty/work
Street address
Iran, Semann, Fatemieh Hospital, Pathology ward
City
Semnan
Postal code
Phone
+98 23 1332 8017
Fax
Email
drtoussy@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)